Project Manager II (Romania)

The Project Manager II oversees and coordinates clinical trials, ensuring compliance with budgets, scope, timelines, and regulatory standards. It involves client interaction, project planning, quality management, budget control, team leadership, and collaboration with various departments.

Location: Romania

Responsibilities

• Serve as primary contact for the Sponsor and provide updates on trial progress.
• Lead study start-up activities including site selection, vendor setup, and regulatory submissions.
• Ensure study deliverables are audit-ready and manage quality and risk.
• Control project budget, timelines, and resources, and manage recruitment and operational aspects.
• Lead the project team, ensure training, and coordinate with internal and external stakeholders.

Requirements

• B.Sc. in a related field of study to clinical research.
• At least 5 years industry experience and 3 years in Phase I-III clinical trial project management.
• Experience managing dermatology and/or rheumatology trials.
• Experience leading multi-centered trials with budgets over $3M USD.
• Knowledge of GCP, ICH standards, FDA, and Canadian regulations.
• Excellent communication, organizational, and problem-solving skills.

Benefits

• Permanent full-time position.
• Flexible schedule.
• Vacation.
• Home-based position.
• Ongoing learning and development.